Trial Outcomes & Findings for LARC Forward Contraceptive Counseling at MHCC (NCT NCT02735551)
NCT ID: NCT02735551
Last Updated: 2019-11-12
Results Overview
Proportion of Long Acting Reversible Contraception (LARC) uptake among women, by group assignment. This will be evaluated based on participants' self-reported ongoing use and satisfaction by group assignment on the 3-month questionnaire after the initial visit. 3 months following placement of LARC device, initiation of short acting method, and those in the control group, participants will complete a questionnaire in order to assess ongoing use and satisfaction of their contraceptive method. This will be measured on the 3-month questionnaire.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
3 participants
Primary outcome timeframe
3 months
Results posted on
2019-11-12
Participant Flow
Participant milestones
| Measure |
Non-LARC Group: Short Acting Method
All groups will receive the same standardized contraceptive counseling ("LARC forward counseling"). Participants who chose a short-acting hormonal method (e.g. contraceptive pills, ring, or patch) will receive a prescription to the pharmacy of their choice, as is the current practice for students who present for contraceptive services
Prescription for Short-Acting Hormonal Contraception: Participants who chose a short-acting hormonal method (e.g. contraceptive pills, ring, or patch) will receive a prescription to the pharmacy of their choice
|
Control Group: Referral for LARC Placement
All groups will receive the same standardized contraceptive counseling ("LARC forward counseling"). Randomized to referral for LARC placement to local clinic.
Referral for Long Acting Reversible Contraception (LARC): Referral to local clinic for LARC placement of choice (Mirena, Skyla, Paragard, Implanon, etc.)
|
LARC Group: Same Day LARC Placement
All groups will receive the same standardized contraceptive counseling ("LARC forward counseling"). Randomized to same day LARC placement (intervention).
Long Acting Reversible Contraception (LARC): Same day LARC placement (intervention) of Mirena, Skyla, Paragard, Implanon
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
0
|
0
|
|
Overall Study
COMPLETED
|
3
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
LARC Forward Contraceptive Counseling at MHCC
Baseline characteristics by cohort
| Measure |
Non-LARC Group: Short Acting Method
n=3 Participants
All groups will receive the same standardized contraceptive counseling ("LARC forward counseling"). Participants who chose a short-acting hormonal method (e.g. contraceptive pills, ring, or patch) will receive a prescription to the pharmacy of their choice, as is the current practice for students who present for contraceptive services
Prescription for Short-Acting Hormonal Contraception: Participants who chose a short-acting hormonal method (e.g. contraceptive pills, ring, or patch) will receive a prescription to the pharmacy of their choice
|
Control Group: Referral for LARC Placement
All groups will receive the same standardized contraceptive counseling ("LARC forward counseling"). Randomized to referral for LARC placement to local clinic.
Referral for Long Acting Reversible Contraception (LARC): Referral to local clinic for LARC placement of choice (Mirena, Skyla, Paragard, Implanon, etc.)
|
LARC Group: Same Day LARC Placement
All groups will receive the same standardized contraceptive counseling ("LARC forward counseling"). Randomized to same day LARC placement (intervention).
Long Acting Reversible Contraception (LARC): Same day LARC placement (intervention) of Mirena, Skyla, Paragard, Implanon
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
—
|
—
|
3 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
21.3 years
STANDARD_DEVIATION 0.58 • n=5 Participants
|
—
|
—
|
21.3 years
STANDARD_DEVIATION 0.58 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
—
|
—
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
—
|
—
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
—
|
—
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
1 Participants
n=5 Participants
|
—
|
—
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American/Black
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian/White
|
1 Participants
n=5 Participants
|
—
|
—
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Latino
|
1 Participants
n=5 Participants
|
—
|
—
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Mutli-racial
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
—
|
—
|
3 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: No participants enrolled in both the Control Group or the LARC Group. All 3 participants analyzed met the criteria specified for this analysis.
Proportion of Long Acting Reversible Contraception (LARC) uptake among women, by group assignment. This will be evaluated based on participants' self-reported ongoing use and satisfaction by group assignment on the 3-month questionnaire after the initial visit. 3 months following placement of LARC device, initiation of short acting method, and those in the control group, participants will complete a questionnaire in order to assess ongoing use and satisfaction of their contraceptive method. This will be measured on the 3-month questionnaire.
Outcome measures
| Measure |
Non-LARC Group: Short Acting Method
n=3 Participants
All groups will receive the same standardized contraceptive counseling ("LARC forward counseling"). Participants who chose a short-acting hormonal method (e.g. contraceptive pills, ring, or patch) will receive a prescription to the pharmacy of their choice, as is the current practice for students who present for contraceptive services
Prescription for Short-Acting Hormonal Contraception: Participants who chose a short-acting hormonal method (e.g. contraceptive pills, ring, or patch) will receive a prescription to the pharmacy of their choice
|
Control Group: Referral for LARC Placement
All groups will receive the same standardized contraceptive counseling ("LARC forward counseling"). Randomized to referral for LARC placement to local clinic.
Referral for Long Acting Reversible Contraception (LARC): Referral to local clinic for LARC placement of choice (Mirena, Skyla, Paragard, Implanon, etc.)
|
LARC Group: Same Day LARC Placement
All groups will receive the same standardized contraceptive counseling ("LARC forward counseling"). Randomized to same day LARC placement (intervention).
Long Acting Reversible Contraception (LARC): Same day LARC placement (intervention) of Mirena, Skyla, Paragard, Implanon
|
|---|---|---|---|
|
Number of Participants Reporting Ongoing Use and Satisfaction
|
3 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Non-LARC Group: Short Acting Method
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group: Referral for LARC Placement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LARC Group: Same Day LARC Placement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ob/Gyn Regulatory Specialist
Oregon Health & Science University
Phone: 5034940757
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place